FDAsafety guidance83% confidence
FDA notification regarding unapproved drugs included in kits
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Cadila Pharmaceuticals.
Regulatory Analysis
On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits.
Supporting Context
- Therapeutic area
- Psychiatry · Antidepressant
- Sub-indication
- General
Related signal: Cadila Pharmaceuticals Issues Class 4 Defect Notification for Mirtazapine 30mg Tablets